INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SODIUM CHLORIDE (SODIUM CHLORIDE)

Composition:

Active substance: sodium chloride;

1 ml of solution contains sodium chloride 9 mg;

Excipient: water for injections.

Pharmaceutical form. Solution for injection.

Main physico-chemical properties: clear, colorless liquid.

Pharmacotherapeutic group.
Plasma substitutes and perfusion solutions. Electrolyte solutions. ATC code B05X A03.

Pharmacological properties.

Pharmacodynamics.

Sodium chloride 9 mg/mL solution normalizes the water-electrolyte balance and eliminates fluid deficiency in the human body that develops during dehydration or due to accumulation of extracellular fluid in large burn wounds and trauma, abdominal surgeries, and peritonitis. The drug improves tissue perfusion and enhances the effectiveness of blood transfusion measures in massive blood loss and severe forms of shock. It also exerts a detoxifying effect due to a transient increase in fluid volume, reduction of toxic metabolite concentration in the blood, and stimulation of diuresis.

Pharmacokinetics.

Rapidly leaves the vascular system. The drug remains in the vascular bed for a short period, after which it passes into the interstitial and intracellular compartments. After 1 hour, only approximately half of the infused solution remains within blood vessels. Salts and fluid are very rapidly excreted by the kidneys, increasing diuresis.

Clinical characteristics.

Indications.

Preparation of solutions of medicinal products for topical and parenteral administration. May be used locally for wound irrigation and nasal mucosa.

Contraindications.

Incompatibility of the main medicinal product with the solvent. The medicinal product should not be used for eye irrigation in ophthalmic surgery.

Interaction with other medicinal products and other forms of interactions.
The medicinal product is compatible with most medicinal products; therefore, it should be used for dissolving various medicinal products—except for those preparations incompatible with sodium chloride as a solvent.

Special precautions.

Before dissolving the medicinal product, it is necessary to check whether the use of sodium chloride solution is suitable for dissolving this medicinal product.

Use during pregnancy or breastfeeding. The drug can be used during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery. Has no effect.

Administration and Dosage.

Administer intravenously, intramuscularly, rectally, or subcutaneously (depending on the recommended route of administration). For wound and mucous membrane irrigation, use sufficient amount of the solution.

Children. The drug can be used in children.

Overdose. Unlikely when used correctly.

Side effects.

Not observed when the medicinal product is used correctly.

Shelf life. 5 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 5 ml or 10 ml in an ampoule, 5 ampoules in a blister, 2 blisters in a carton.

5 ml or 10 ml in an ampoule, 10 ampoules in a box.

Prescription status. Prescription only.

Manufacturer. JSC "Halychpharm".

Manufacturer's address.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.